Documents and
Records
1
Learning Objectives
At the conclusion of this session, you will be able
to:
explain the difference between documents and
records;
describe the hierarchy of documents and the
role of each level;
outline the contents of a quality manual;
outline the content that should be included in a
standard operating procedure;
explain the important steps, or elements, of a
laboratory document management system;
describe methods and tools to properly store
documents and records.
2Documents and Records - Module 16
Scenario
testing algorithm
safety manual
client test results
standard operation
procedures (SOPs) for an
approved HIV rapid test
manufacturer test kit
inserts
summary of findings from
on-site evaluation visit
report of corrective actions
temperature log (blank
form)
quality control record (blank
form)
daily maintenance log
(completed)
stock cards and stock book
(completed)
EQA specimen transfer log
(completed)
You have found all these papers lying on a desk.
Which of these are documents and which are
records?
3Documents and Records - Module 16
The Quality Management System
Organization Personnel Equipment
Purchasing
&
Inventory
Process
Control
Information
Management
Documents
&
Records
Occurrence
Management Assessment
Process
Improvement
Customer
Service
Facilities
&
Safety
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Why do laboratories need to manage
documents and records?
To find information
whenever it is needed!
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Documents and Records—How do they differ?
Documents
communicate
information via
policies, processes,
and procedures
need updating
Records
capture information
on worksheets,
forms, labels, and
charts
permanent, do not
change
RECORDS
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Information is the
major product
of the laboratory
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Procedures Processes
Policies
Laboratory
Documents
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Policies - The “WHAT TO DO”
“A written statement of overall intentions
and directions defined by those in the
organization and endorsed by
management.” (CLSI HS1-A3)
Policies:
tell “what to do” in a broad and general way
include the organizational mission, goals, and
purpose
serve as the framework for the quality system
should always be specified in the quality
manual
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Processes - The “HOW IT HAPPENS”
A “set of interrelated or interacting
activities that transform inputs into
outputs.” (ISO 9000 )
Processes:
describe the steps involved to carry
out quality policies
easily represented in flow charts
involve a series of steps, usually
occurring over a period of time
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Procedures - The “HOW TO DO IT”
Standard operating procedures (SOP)
step-by-step instructions for
performing a single activity
Job aid
a shortened version of the SOP
does not replace the SOP
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Hierarchy of Documents
“How to do it”
“How it happens”
“What to do”
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Why are documents important?
essential guidelines for laboratory
quality manual
SOPs
reference materials
required by formal laboratory standards
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Documents are the communicators
of the quality management system
Verbal instructions often are:
not heard
misunderstood
quickly forgotten
difficult to follow
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Documents are a reflection of
the laboratory’s organization
and its quality management.
A good rule to follow is:
“Do what you wrote and
write what you are doing.”
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Good Documents are:
clear
concise
user-friendly
explicit
accurate
up-to-date
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Documents for work processes should
be accessible to staff at the work site :
instructions on handling incoming samples
SOPs for each test
quality control charts
and trouble-shooting
instructions
safety manuals
and precautions
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The Quality Manual
is a document describing the
quality management system
of an organization
(ISO 15189)
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Quality Manual
communicates information
serves as a framework or roadmap
for meeting quality management
system requirements
demonstrates management
commitment to quality
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Writing a Quality Manual
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Writing a Quality Manual
Form a Steering Committee
Set policy f
or
12 QS
essentials
Describe how
the related
quality
processes occur
Reference
procedures
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Key Points: Quality Manual
only ONE official version
never “done”, always being
improved
read and accepted by everyone
use the best-adapted language
Very big job, but very useful
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Standard Operating Procedures
(SOPs) are documents that:
describe how to perform a test
using step-by-step instructions
written SOPs help ensure:
consistency
accuracy
quality
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A Good SOP
provides detailed, clear, and concise
direction for testing techniques
is easily understood by new
personnel
is reviewed and approved by
management
is updated on a regular basis
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Standardized SOP Format
Computerized procedure
Standardization:
Header
Version/chapter/reference
Author/reader/validator
Recipients
Version date/Application
date
Typical outline
Updating and storage of
different versions is easy
J Johnson,
RB Smith
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Complete Standardized Header
Use at the top of the first page only
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Reduced Standardized Header
other pages of every procedure
use at the top of all other pages
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When Preparing SOPs
establish
means for
updating
gather all
documents
include
each step
assess
scientific
validity
determine
procedure
to use
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Suggested Outline for SOPs
Title: Name of Test
Purpose: Medical use
Instructions:
Preexamination
Examination
Postexamination
References to verify the method is
established
Author’s name
Approval signature(s)–initial and date
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Avoid Drowning in Detail…..
BAD EXAMPLE: “The purpose
of this procedure is to
document the
aforementioned activities,
herin after referred to as the
prescribed tasks in terms
that preclude their execution
in an inconsistent manner,
wherin such inconsistency
may potentially result in the
prescribed tasks delivering a
result that is not repeatable
or reproducible”…
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Do not rely solely on manufacturer
product inserts
Inserts do not provide specific
information for test sites,
such as:
materials required, but not in kit
specific safety requirements
external quality control requirements
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Job Aids
shortened version of SOPs
hand written or printed
visible location at testing site
useful tool to assure all testing steps
are correctly performed
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Job Aids
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Job Aids
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Document Control
assures that the
most current
version is used
ensures availability
when needed
organizational tool
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Document Control Elements
system for organizing, such as
numbering or coding system
approval, distribution, and revision
process
master log that describes which
documents are in circulation
accessibility of documents at the
point of use
system for archiving
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equipment
service
manuals
SOPs
texts,
articles,
reference
books
Controlled
documents
regulations
and
standards
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Documents of External Origin
Include in the laboratory document
control system:
instrument service manuals
industry regulations
ISO standards
references used for documentation
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Numbering System
need uniform numbering system
do not change a current system that works
one system: letter for the type of document
and then an incremented number: B1, B2,
B3 for books and T1, T2 for official texts
number all pages of document
reference by document code, pages,
location code: Book number 2, pages 188-
200, on bookshelf 1: B2,188-200, BS1
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Document Preparation and
Control Process
Preparation
Review
Issue
Distribution
Revision Approval
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Implementing Document Control
collect existing documents and
records
review and update
determine additional needs
develop or obtain documents, forms,
worksheets, logbooks, reports
involve stakeholders
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Common Document Control Problems
outdated documents
too many documents are
distributed and the system
cannot be maintained
lack of control of documents
of external and internal origin
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Why are records essential?
Sample
tracking
throughout
process
Management
tool
Identify
problems
Continuous
monitoring
of
quality
system
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Patient
test reports
EQA /
PT records
Quality
control
data
Maintenance
records
Instrument
printouts
Workbooks
Worksheets
Sample
log book
or register
Laboratory
Records
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Critical
communications
Customer
feedback
User
surveys
Continuous
improvement
External
audits
results
Internal
audits
results
Personnel
records
More
Records
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Keep the Things You Might
Forget!
disposition of rejected samples
referral of samples to another
laboratory
records of adverse occurrences or
problems
inventory and storage records
equipment purchase data,
preventive maintenance, and
troubleshooting
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Test Report Contents ISO 15189
test identification
laboratory identification
patient unique
identification and location
name and address of
requestor
date and time of
collection
time of receipt in lab
date and time of release
of report
primary sample type
results (SI units)
biological reference
intervals
interpretive comments
person authorizing
release, with signature
when possible
note if reporting a
corrected result
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Paper Systems
Permanence
• bind books
• number pages
• use permanent ink
• control storage
Accessibility
use system that will
allow ease of access
Security
maintain
confidentiality
keep safe from
environmental
hazards
Traceability
allow for tracking of a
specimen throughout
all processes
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Electronic Systems
permanence
computer system maintenance, backups
security
access
confidentiality
traceability
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Testing
process
review
Time
between
assessments
-audits
Research
purposes
National
legislation
and
regulation
Factors
affecting
retention
times
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Summary
Documents:
include written policies, processes, and procedures
need to be updated and maintained
Records:
include information captured in processes
are permanent, do not require updating
A good document control program:
most current version used
availability and ease of access
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Key Messages
Information is our product.
Documents are essential for assuring
accuracy and consistency in the
laboratory.
53Documents and Records - Module 16
Scenario
testing algorithm
safety manual
client test results
standard operation
procedures (SOPs) for an
approved HIV rapid test
manufacturer test kit
inserts
summary of findings from
on-site evaluation visit
report of corrective actions
temperature log (blank
form)
quality control record (blank
form)
daily maintenance log
(completed)
stock cards and stock book
(completed)
EQA sample transfer log
(completed)
You have found all these papers lying on a desk.
Which of these are documents and which are
records?
54Documents and Records - Module 16
Scenario
testing algorithm
safety manual
client test results
standard operation
procedures (SOPs) for an
approved HIV rapid test
manufacturer test kit
inserts
summary of findings from
on-site evaluation visit
report of corrective actions
temperature log (blank
form)
quality control record (blank
form)
daily maintenance log
(completed)
stock cards and stock book
(completed)
EQA sample transfer log
(completed)
You have found all these papers lying on a desk.
Which of these are documents and which are
records?
55Documents and Records - Module 16
Questions?
Comments?
Organization Personnel Equipment
Purchasing
&
Inventory
Process
Control
Information
Management
Documents
&
Records
Occurrence
Management Assessment
Process
Improvement
Customer
Service
Facilities
&
Safety
56Documents and Records - Module 16
